Vaccine Therapy in Treating Patients With Liver Cancer

Jonsson Comprehensive Cancer Center

Status and phase

Completed

Phase 2

Phase 1

Conditions

Liver Cancer

Treatments

Biological: AFP

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00022334

CDR0000068806

NCI-G01-1997

UCLA-0001026

Details and patient eligibility

About

RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have liver cancer.

Full description

OBJECTIVES:

Determine the maximum tolerated dose of alpha-fetoprotein peptide-pulsed autologous dendritic cells in HLA-A*0201-positive patients with hepatocellular carcinoma.
Determine the safety and toxicity of this regimen in these patients.
Determine the immunological effects of this regimen in these patients.
Determine the progression-free survival and clinical responses in patients treated with this regimen.

OUTLINE: This is a dose-escalation study.

Patients receive alpha-fetoprotein peptide-pulsed autologous dendritic cells intradermally on day 1. Treatment repeats every 2 weeks for a total of 3 doses in the absence of unacceptable toxicity.

Cohorts of 3-12 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 2 of 12 patients experience dose-limiting toxicity.

Patients are followed at weeks 1, 4, and 12 and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

HLA-A*0201 positive adults over the age of 18.
Have HCC with a serum AFP determination >30ng/ml.
Both male and female patients may be enrolled.
Karnofsky Performance Status greater than or equal to 70 percent.
No previous evidence of class 3 or greater New York Heart Association cardiac insufficiency or coronary artery disease.
No previous evidence of opportunistic infection.
Adequate baseline hematological function as assessed by the following laboratory values with 30 days prior to study entry:
1. Hemoglobin >9.0g/dl
2. Platelets >50000/mm3
3. Absolute Neutrophil Count >1,000/mm3
Child-Pugh Class A or B for chronic liver disease.
Ability to give informed consent.

Exclusion criteria

Any congenital or acquired condition leading to inability to generate an immune response, including concomitant immune suppressive therapy.
Concomitant steroid therapy or chemotherapy, or any of these other treatments < 30 days before the first vaccination.
Females of child-bearing potential must have negative serum beta-HCG pregnancy test (within Day -14 to Day 0).
Acute infection: any acute viral, bacterial, or fungal infection, which requires specific therapy. Acute therapy must have been completed within 14 days prior to study treatment.
HIV-infected patients.
Patients with any underlying conditions which would contraindicate therapy with study treatment.
Patients with organ allografts.
O2 sat <91% on room air; dyspnea at rest.